[SARS-CoV2/코로나 검사 키트] Volcano3G® Direct COVID-19 Kit [6901]_myPOLS Biotec/Medix Biochemica - 코아사이언스

Volcano3G® Direct COVID-19 Kit 

Cat.# 6901 / Size:  100x reactions (30 µl)

Cat.# 6901_500 / Size:  500x reactions (30 µl)

Cat.# 6901_1000 / Size:  1000x reactions (30 µl)

 

Description 

This test is for general laboratory use.

This kit is intended to detect SARS-CoV2 in samples of extracted and non-extracted patient samples. The duplex assay covers SARS-CoV2 N1-gene (FAM-channel) and human RNaseP-gene (Cy5-channel) simultaneously.

Acceleration of SARS-CoV-2 testing: Simply skip the step of RNA extraction. 

• Works from RNA extracts as well as from crude samples
• RT-PCR primers & probes design as in CDC protocol
• Super fast turnaround time: from sample to result 1h* (* = this is depending on real-time PCR cycler speed, when working with non-extracted samples)
• Ideal for screening of large cohorts under time pressure
• Easy delivery: Shipped on ice-packs, world-wide
   

The kit contains our thermostable Volcano3G® Master Mix and a duplex primer/probe mix for both SARS-CoV-2 (N1 gene specific) and RNaseP control.

This test is not affected by following mutations: B.1.1.7 (British/Alpha), B.1.351 (Southafrican/Beta), B.1.1.28 (Brazilian/Gamma), B.1.525, B.1.617 (Indian/Delta).

 

Applications 

Rapid detection and identification of SARS-CoV-2

The Volcano3G® Direct COVID-19 Kit enables the application of a simple RT-PCR protocol with and without the time-consuming and costly isolation of viral SARS-CoV-2 RNA. The core element is an optimized, thermostable DNA polymerase that is optimized to convert the SARS-CoV-2 genetic material (part of the N1 gene) from RNA to DNA and to start amplification of the DNA in one, single step. 

For example, the University of Konstanz is employing this PCR kit in a campus-wide surveillance study of symptom-free staff and students who are tested at least once a week. For details, please have a look at campus.kn - The online magazine of the University of Konstanz (Link)

 

Development 

The method was originally developed and validated in cooperation with a DAkkS accredited laboratory, the University of Konstanz, and the Konstanz Clinics (see peer-reviewed publication below).

myPOLS Biotec has further developed the method to a duplex format that detects both, SARS-CoV-2 (N1 gene specific) and the RNaseP-based control in one reaction.

The Volcano3G® Direct COVID-19 Kit enables a simple RT-PCR-based detection method without the time-consuming and costly isolation of viral SARS-CoV-2 RNA. 

Publication: "Detection of SARS-CoV-2 from raw patient samples by coupled high temperature reverse transcription and amplification"

 

Manual 

Short Version Manual -Volcano3G® Direct COVID-19 Kit

Instructions for use - in English - Volcano3G® Direct COVID-19 Kit

 

FAQ 

Which mutations affect the test?
This test is not affected by following mutations: B.1.1.7 (British/Alpha), B.1.351 (Southafrican/Beta), B.1.1.28 (Brazilian/Gamma), B.1.525, B.1.617 (Indian/Delta).

How do I have to ship & store the mix?
Volcano3G® Direct COVID-19 Kit IVD is shipped on cool packs (<10 °C).
For long term storage, Volcano3G® Direct COVID-19 Kit should be stored between -25 °C and -15 °C after arrival. The direct booster solution must be stored between +4 and +12 °C.

Can I also use swabs without RNA extraction?
Our kit has been optimized and validated with gargling solutions (5ml pure water gargled for 20-30 sec) and RNA extracts of such. Compatibility with different samples, such as citoswabs, eswabs or dry swabs has been shown but not validated - e.g. Dry-swabs can be eluted in 350 µl of PCR-clean water and then subsequently be added directly to a PCR. Swabs eluted in storage medium such as VTM will lead to decreased sensitivity when used directly.
For all samples other than gargling solutions, we recommend to use extracted RNA samples.

Can I use gargle samples which are already half a day old?
Yes. Ideally, the samples are tested fresh, but gargle samples can be transported at room-temperature and can be kept for a few days in a fridge or frozen.

Is the product suitable for self-testing?
The product is not intended for self-testing, but only for professional use by qualified laboratory personnel trained in sample processing techniques, RT-PCR and in vitro-diagnostic processes.

Do I have to denature the gargle samples before PCR?
We recommend to denature the solution for at least 3 min at 95°C before PCR. This inactivates pathogens and renders the sample more homogeneous, which makes pipetting easier. Please note that denatured samples should be kept cold and tested within 3 hours of denaturation.

PCR signals are inconsistent with weak reproducibility?
Make sure to work in an RNase-free environment and keep all components cold during pipetting. Spin down PCR-ready, sealed plates in a centrifuge to collect all liquid at the bottom of the well and remove bubbles.

My positive control does not give a signal?
Make sure all components were pipetted correctly and the cycler setting are as required. Do not vortex the positive control during thawing. Mix by gently flicking the tube and collect the liquid at the bottom by short centrifugation to avoid contaminations. To avoid DNase contaminations and freeze-thaw cycles, positive control may be aliquoted into smaller aliquots for day-to-day use.

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